FDA applicant
Esaote, S.p.A.
FDA records 69 decisions for Esaote, S.p.A. (Indianpolis, IN) from 2003 to 2026: 69 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LNH (System, Nuclear Magnetic Resonance Imaging). Since 2016 its 510(k)s took a median of 81 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 215 predicates, 138 of them its own earlier devices. 14 recalls are linked to its devices.
FDA’s records also spell it “Esaote”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Esaote, S.p.A.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Esaote, S.p.A.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Esaote”
FDA records each applicant name separately; these may or may not be the same firm.